FDA panel says drug intended to stop premature birth should be withdrawn

FDA advisory panel said it remains doubtful that Makena, a drug intended to prevent premature births works. The panel voted to recommend the FDA withdraw its approval.

An advisory panel to the Food and Drug Administration voted Wednesday to take a drug intended to prevent premature births off the market, saying that it remains doubtful that the drug works.

The recommendation, in a 14-1 vote, from the agency’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee closed a three-day meeting on the clinical trial evidence supporting Makena, the only drug approved in the U.S. to prevent preterm births.

The meeting included emotional testimony, including from advocates who said removing the drug could deepen maternal health inequities.

The panel voted on three questions: whether the drug is effective, whether trial data support its approval and whether it should remain on the market. The panel voted no on each question.

“It would be unfair to keep the drug on the market and expose especially vulnerable populations to an ineffective therapy,” said panel member Dr. Mark Hudak, a pediatrician at the University of Florida College of Medicine in Jacksonville.

https://www.nbcnews.com/health/health-news/fda-panel-says-drug-intended-stop-premature-birth-withdrawn-rcna52789


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